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CHICAGO — Proposed U.S. guidelines may make it easier for drug companies to test Alzheimer’s
treatments in people at an earlier stage, when scientists think they might have the best shot at
working.

The draft guidance document, issued yesterday by the U.S. Food and Drug Administration, reflects
changes in scientists’ understanding of Alzheimer’s. They now think the disease begins at least a
decade before symptoms appear.

“The scientific community and the FDA believe that it is critical to identify and study patients
with very early Alzheimer’s disease before there is too much irreversible injury to the brain,”
said Dr. Russell Katz, director of the Division of Neurology Products in the FDA’s Center for Drug
Evaluation and Research.

Current Alzheimer’s drugs treat symptoms, but none has been proved to interrupt the steady
destructive course of Alzheimer’s that robs sufferers of their memories and independence.

“I think this will be hugely useful to the pharmaceutical industry,” said Dr. Paul Aisen of the
University of California, San Diego, and director of the Alzheimer’s Disease Cooperative Study, an
effort between the university and the National Institute on Aging to identify the earliest signs of
Alzheimer’s.

Aisen said the draft document will help companies design clinical trials to test drugs in people
before dementia strikes, such as prodromal disease, a precursor to Alzheimer’s in which mild
cognitive changes have occurred and there is some biomarker evidence, such as a brain scan, that
suggests the changes are related to Alzheimer’s disease.

The need for new treatments is great and growing. A study on Wednesday suggested that the number
of Americans with Alzheimer’s disease would triple to 13.8 million by 2050.